Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

October 7, 2020 updated by: Mona Salem

Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer: A Single Institution Feasibility Study

The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks in Kasr EL Aini Hospital.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Histologically proven diagnosis of invasive breast adenocarcinoma.
  2. Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery).
  3. No macroscopic evidence of distant metastases at diagnosis.

Exclusion Criteria:

  1. Prior radiation to the thoracic region.
  2. Pregnancy.
  3. Patients with synchronous or prior malignancy.
  4. Positive surgical margins.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionation
Hypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions.
Radiation: Weekly hypofractionation for early breast cancer
Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cosmetic breast appearance
Time Frame: six months
according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor
six months
Acute radiation toxicity assessment
Time Frame: six months
according to the RTOG acute toxicity scale: 0 No visible change, 1 faint/dull erythema, 2tender/ bright +- dry desquamation, 3 patchy moist desquamation, 4 conflueunt moist desquamation, pitting edema, 0 is the best and 4 is the worse.
six months
Patient quality of life assessment.
Time Frame: six months
according to FACT-B
six months
Patient satisfaction.
Time Frame: six months
according to FACIT-TS-PS
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mona Salem

Collaborators

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Mona Salem, MSc, Kasr El AiniH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2018

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAST feasibility in CU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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